Since the mid-nineteenth century, medical professionals have recognized the need for maintaining sterile conditions, especially in operating rooms. Joseph Lister, “On the Antiseptic Principle of the Practice of surgery” (1867); Vol. XVIII, Part 6. The Harvard Classics. New York: P.F. Collier & Son, 1909-14.Thus, equipment covers, patient drapes, and other medical supplies often are used only a single time. In addition, ready-to-use articles are frequently purchased from commercial manufacturers. Alternatively, the articles, whether reusable or single-use, may be processed within a facility providing health care such as a hospital, surgical center, clinic or office. The processor must package the article in a manner that will protect and maintain both the sterility of the article and the sterility of the surgical field during the introduction of the article.
Various sterilization treatments exist, such as, for example, steam, ethylene oxide, radiation, formaldehyde, hydrogen peroxide, peracetic acid, glutaraldehyde, ozone, and dry-heating. Traditionally, many articles intended for use in a surgical field are double packaged in a completely sealed outer packaging element that surrounds an inner packaging element in or on which the sterilizable article is located. The double-packaged article is sterilized so that when the article arrives at the point of use, both the article and the inner packaging element are sterile.
It is particularly important that sterile technique be practiced during unwrapping or during opening of a package. For example, sterile technique does not allow a hand or object to contact a sterile article. To introduce a double-packaged sterile article onto a sterile field, typically a non-scrubbed attendant opens and discards the outer packaging element surrounding the inner packaging element and the article. The attendant then carefully opens the inner packaging element and presents the sterile article to scrubbed personnel for transfer to the sterile field. The non-scrubbed attendant must exercise great care in order to maintain the sterility and integrity of the article and thus the sterile field.
The inner packaging element is intended to provide a second level of protection and to maintain the sterility of the article and of the sterile field during introduction of the article. An example of a typical inner packaging element employs a double-layered muslin cloth, commonly known as a central supply wrap (CSR), a name that originally identified the hospital central supply department as the source of the packaged article. In a CSR wrap, an article is placed on a diagonal in the center of a square sheet of fabric that is proportionally sized to adequately enclose the article. Each corner of the sheet is folded over the article sequentially, and the fourth corner is tucked under the first three proximate the center of the article. The end of the fourth corner is left exposed for later opening of the package.
When opening a CSR wrap, the non-scrubbed attendant holds the package in one hand and with the other hand grasps the exposed corner at the tab, pulls the corner of the sheet away from the attendant around and under the holding hand, and tucks the corner into the holding hand. The attendant pulls each corner of the sheet away from the article and around the holding hand, tucking the corners between the fingers of the holding hand to provide a protective hand cover. Since only the holding hand has a protective cover when the article has been exposed, the non-scrubbed attendant preferably is assisted by a second, scrubbed person who removes the sterile article from the holding hand and who actually introduces the sterile article onto the sterile field.
When the non-sterile attendant is opening the CSR wrap, if any edge of the sheet escapes the holding hand or inadvertently touches the sterile article, the article has been contaminated. Discarding the contaminated article increases the cost of the procedure, both in terms of actual articles used and total time expended during the procedure. In addition, CSR wrap is prone to fluid strike-though and exhibits tearing with extended use. Further, sterilization methods employing cloth wrap are normally practiced by first unwrapping the sterilized tray, followed by moving the unwrapped tray to an area where the tray contents will be used. Because sterile technique requires careful and precise procedures, cloth wrap practice is time consuming and expensive.
An alternative practice replaces muslin wrap with a disposable non-woven CSR wrap applied in the same manner. Although non-woven CSR wraps offer improved fluid resistance and improved bacterial barrier migration over cloth counterparts, sterilization practices that use these nonwoven materials are still labor intensive and costly.
In addition, attempts exist in the prior art to address the need for a packaging system that permits opening of the system without significant risk of contamination or damage to the article combined with easy aseptic presentation of the article for use. In one prior art approach, a packaging system includes a sterilizable, flexible, elongate-tubular member having an outside, a closed end and an open end. A sterilizable article is placed into the sterilizable tubular member so that the article contacts a portion of an inside surface at the closed end of the tubular member. A border portion with a first edge and a second edge is formed on the tubular member. The first edge of the border portion is attached to the tubular member proximate an opening in the tubular member for the opening. The second opposing edge of the border portion is spaced apart from the first edge by a width of the border portion. A fold line is formed in the border portion and the tubular member above the article. The article is enclosed in the tubular member by placing the first edge of the border portion under the second edge of the border portion between the border portion and the tubular member. After sterilization, the article can be dispensed from the sterile tubular member and transferred onto a sterile field by a single non-scrubbed attendant while maintaining the sterility and integrity of the article and the field.
While these type of packaging systems improve the time and costs of presenting sterilized articles, the danger of contamination is still nevertheless real and present. If such a contaminated article is introduced onto the sterile field, the entire field will be contaminated and the potential for post-operative infection increased, which increases both the cost and the risk of the medical procedure.
In attempting to address this risk, the Association for the Advancement of Medical Instrumentation (“AAMI”), 1110 North Glebe Road, Suite 220, Arlington, Va. 22201-4795 and the Association of periOperative Registered Nurses (“AORN”), 2170 South Parker Rd, Suite 300, Denver, Colo. 80231-5711 standards state that an internal chemical indicator should be used within each package to be sterilized. The internal indicator may be a single-parameter indicator (Class 3), mulit-parameter indicator (Class 4) or integrating indicator (Class 5), depending on the complexity of the pack and contents. Thus, an independent indicator strip is typically placed into prior art packaging. However, when an article is aseptically presented as described above, the strip often falls to the floor, is not be easily seen, and can lead to non-optimal aseptic delivery.
What is thus needed is a packaging system that minimizes the time and costs of presenting sterilized articles. Such article should decrease the instances in which the attendant is unaware of a contamination, thereby decreasing the potential for post-operative infection.